BioMerieux mini APT User manual

Ref. 99709

Version C

11/2003

mini API

Instrument User's Manual

Tel. [phone] - Fax [phone]

bioMérieux® SA 69280 Marcy l'Etoile / France

http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon

V. AB 09.2003

Argentina

bioMérieux Argentina s.a.
Av. Congreso 1745
(C1428BUE) Capital Federal
Buenos Aires
tel. [phone]
fax [phone]

Australia

bioMérieux Australia Pty. P/L
Unit 25, Parkview Business Center
1 Maitland Place
Baulkham Hills NSW 2153
tel. [phone]
fax [phone]

Austria

bioMérieux Austria GmbH

Eduard-Kittenberger-Gasse 97
Top 3
A-1230 Wien
tel. [phone]
fax [phone]

Belgium

bioMérieux Benelux s.a./n.v.

Media Square
18-19 Place des Carabiniers
Bruxelles 1030
tel. [phone]
fax [phone]

Brazil

bioMérieux Brasil SA

Estrada Do Mapuá
491 Jacarepaguá
CEP 22710 261 Rio de Janeiro R.J
tel. [phone]
fax [phone]

Canada

bioMérieux Canada, Inc.
4535, Dobrin
Saint Laurent (Québec) H4R 2L8
tel. [phone]
fax [phone]

Chile

bioMérieux Chile S.A.
Seminario 131
Providencia
Santiago
tel. [phone]
fax [phone]

China

bioMérieux China Limited

Unit 1701-2, 17/F, Nanyang Plaza
No. 57 Hung To Road, Kwun Tong
Kowloon - Hong Kong
tel. [phone]
fax [phone]

Colombia

bioMérieux Colombia Ltda
Diagonal 109 # 20A - 33
Bogotá
tel. [phone]
fax [phone]

Denmark

bioMérieux Danmark Aps

Smedeholm 13C,
2730 Herlev
tel. [phone]
fax [phone]

Finland

bioMérieux Suomi Oy
Rajatorpantie 41 C
01640 Vantaa
tel. [phone]
fax [phone]

France

bioMérieux SA
69280 Marcy l’Etoile
tel. [phone]
fax [phone]
http://www.biomerieux.com

Germany

bioMérieux Deutschland GmbH
Weberstrasse 8
D 72622 Nürtingen
tel. [phone]
fax [phone]

Greece

bioMérieux Hellas S.A.

Papanikoli 70
15232 Halandri
Athens
tel. [phone]
fax [phone]

India

bioMérieux India Pvt. Ltd

D-45, Defense Colony
New Delhi 110 024
tel. [phone]
fax [phone]

Indonesia

bioMérieux Asean

Enseval Building
Kawasan Industri Pulo Gadung - JI. Pulo
Lentut No. 10
Djakarta Timur 13920
tel. [phone]
fax [phone]

Italy

bioMérieux Italia S.p.A.

Via Fiume Bianco, 56
00144 Roma
tel. [phone]
fax [phone]

Ivory Coast

bioMérieux Afrique Occidentale

08 BP 2634
Rue Joseph Blohorn - Cocody
Abidjan 08
tel. [phone]
fax [phone]

Japan

bioMérieux Japon, Ltd.

Seizan Bldg.,
12-28 Kita-Ayoama 2-chome
Minato-ku, Tokyo 107-0061
tel. [phone]
fax [phone]

Korea

bioMérieux Korea Co., Ltd.

7th floor Yoosung Building
# 830-67, Yoksam-dong, Kangnam ku
Séoul
tel. [phone]
fax [phone]

Mexico

bioMérieux México SA de CV

Chihuahua 88, col. Progreso
México 01080, D.F.
tel. [phone]
fax [phone]

Netherlands (The)

bioMérieux Benelux BV

Boseind 15
P.O. Box 23
5280 AA Boxtel
tel. [phone]
fax [phone]

New Zealand

bioMérieux New Zealand Ltd.

22/10 Airbourne Road
North Harbour
Auckland
tel. [phone]
fax [phone]

Norway

bioMérieux Norge AS

Ækernveien 145
N - 0513 Oslo
tel. [phone]
fax [phone]

Philippines (The)

Representation office

bioMérieux Philippines

11th Floor, Pearlbank Centre
146 Valero Street, Salcedo Village
1227 Makati City
tel. [phone]
fax [phone]

Poland

bioMérieux Polska Sp. Z o.o.

ul. Zeromskiego 17
01-882 Warszawa
tel. [phone]
fax [phone]

Portugal

bioMérieux Portugal, Lda.

Rua Alto do Montijo, Lotes 1 e 2
Portela de Carnaxide
2794-070 Carnaxide
tel. [phone]
fax [phone]

Russia

o.o.o. bioMérieux

Petrovsko-Razoumovskii proyezd, 29
127287 Moscow
tel. [phone]

(7) 095 424 79 38

fax [phone]

Spain

bioMérieux España s.a.
Manual Tovar, 36
28034 Madrid
tel. [phone]
fax [phone]

Sweden

bioMérieux Sverige AB

Hantverksvägen 15
436 33 Askim
tel. [phone]
fax [phone]

Switzerland

bioMérieux Suisse s.a.

51, avenue Blanc
Case postale 2150
1211 Genève 2
tel. [phone]
fax [phone]

Taiwan

Representation office

bioMérieux China Limited - Taiwan
Branch

RM 608, No. 6-3 Ching Cheng Street
Taipei 105
tel. [phone]
fax [phone]

Thaïland

bioMérieux Thaïland Ltd

Regent House Bldg, 16 th Floor
183 Rajdamri Road, Lumpini, Pathumwan
Bangkok 10330
tel. [phone]
fax [phone]

Distribution in over 130 countries

Turkey

bioMérieux Diagnostik A.S.

Yenisahra Mah.
Caliskan Sok. No. 4
34746 Kadiköy / Istanbul
tel. [phone]
fax [phone]

United Kingdom

bioMérieux UK Ltd

Grafton way, Basingstoke
Hampshire RG22 6HY
tel. [phone]
fax [phone]

USA

bioMérieux, Inc.

100 Rodolphe Street
Durham NC 27712
tel. [phone]
fax [phone]

Vietnam

Representation office

bioMérieux Vietnam Rep. Office

Sai Gon Center Bldg. 11
65 Le Loi District 1
Ho Chi Minh City
tel. [phone]
fax [phone]

th

Fl.

V.A 09/2003

This document will be updated for each software modification or any other change.

Information supplied in this document is subject to modification before the products
described become available.

This document may contain information or references concerning certain
bioMérieux
however, shall not mean that bioMérieux
products, programs or services in such country.

To request copies of publications or for any technical request, contact
bioMérieux

Liability disclaimer

bioMérieux® SA disclaims all warranties, guarantees or liabilities, express or implied
arising by law or otherwise with respect to this manual, its quality, accuracy or
performance, including without limitation, any obligation of bioMérieux
respect to MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE, non­infringement and consequential or incidental damages. IN NO EVENT SHALL
bioMérieux
REFUND OF THE AMOUNT PAID TO bioMérieux
SERVICE WHICH IS THE SUBJECT OF THE CLAIM.

In no event shall bioMérieux
have the right to modify the manual without notice.

®

SA products, programs and services not available in such country; this,

®

SA or your local distributor.

®

SA’ s LIABILITY TO CUSTOMER UNDER ANY CLAIM EXCEED A

®

SA be bound by the manual. bioMérieux® SA shall

®

SA intends to commercialize such

®

SA with

®

SA FOR THE PRODUCT OR

bioMérieux® SA Copyright

This manual, its content and graphics are copyrighted by bioMérieux® SA.

In no event does bioMérieux
reproduction, adaptation or translation, by any process and in any country
whatsoever.

All editorial content and graphics (including without limitations, all articles, text ,
images, logos, compilations, designs) are protected by French Copyright Law and
international treaties and may not be copied without the express permission of
bioMérieux

Any representation or reproduction whether partial or integral, by any process
whatsoever, would therefore be considered fraudulent and sentenced by the
applicable law.

®

SA.

®

SA concede to the manual's user any right for

The logo is a registered and protected trademark of bioMérieux

®

SA or one of its subsidiaries.

General warnings

DANGER ! All biological fluids should be considered as potentially infectious.

Protective gloves must be worn when manipulating blood, products

derived from blood or objects contaminated with blood.

Qualified laboratory personnel should use acceptable procedures for

biohazardous material.

IMPORTANT! The user is advised to read and understand all instructions in this manual

to be able to derive the best performance from the mini API

®

The accuracy of results obtained with this instrument depends, in
particular, on the maintenance operations described in this manual.

The user should be aware that if the maintenance operations are not
performed, are only partially performed, or are not performed as described
in this manual, bioMérieux

®

SA is in no case liable for any false test

results obtained.

The configuration that you have purchased is adapted to the legislation
and standards of the different countries it will be sent to.
For this reason, it may differ from the one presented in this document.
However it will not prevent mini API

®

from operating correctly.

WARNING! This product is an in vitro diagnostic medical device. It complies with the

directives and standards mentioned in the certificate supplied with it.

However, this instrument may cause harmful interference if not installed in
accordance with the instruction manual.

bioMérieux

®

SA recommends that you observe the different warnings
inscribed on the instrument itself and indicated in the documentation
supplied.

.

WARNING! Changes to the equipment not expressly approved by bioMérieux® SA

could void conformity and thus the user’s authority to operate the
equipment. The user will be required to repair damage at his own expense.

bioMérieux

â

SA is in no case liable for any damage that may arise from
failure to comply with technical specifications in this manual, from the
handling of biological fluids or any operation conducted on the equipment
not in compliance with these mandatory standards.

Revisions

The list of revision below summarizes replacements or additional pages in your

mini API

®

Instrument User's Manual.

Manual Reason Page(s)

V.B 04/2001 New format (7x9) All

V.C 10/2003 CE marking Cover page

Chapter 1
Chapter 6

mini API

®

Instrument User's Manual Revisions-1

Table of contents

List of figures VI-1

1

How to use this manual 1-1

Introduction ............................................................................................................................................... 1-1

Finding topics and procedures .................................................................................................................. 1-2

Typographic conventions.......................................................................................................................... 1-3

Graphic symbols ....................................................................................................................................... 1-4

2 Functional description of mini API® 2-1

Introduction ............................................................................................................................................... 2-1

Description / aim ....................................................................................................................................... 2-1

Configuration components........................................................................................................................ 2-2

Hardware ........................................................................................................................................... 2-2

Software............................................................................................................................................. 2-2

Consumables..................................................................................................................................... 2-2

General features and technical specifications of the analyzer .................................................................. 2-4

Environmental conditions ...................................................................................................................... 2-4

Physical features................................................................................................................................... 2-4

Electrical characteristics ........................................................................................................................ 2-5

Characteristics of optical components................................................................................................... 2-5

Principle of operation ................................................................................................................................ 2-7

Turbinephelometric reading................................................................................................................... 2-7

Colorimetric reading .............................................................................................................................. 2-8

3 Preliminary instructions 3-1

Introduction ............................................................................................................................................... 3-1

Recommendations for installation and use ............................................................................................... 3-1

Unpacking mini API®................................................................................................................................3-2

Assembly and installation.......................................................................................................................... 3-3

Choosing a location............................................................................................................................... 3-4

Setting up the strip carriage................................................................................................................... 3-5

Connections .......................................................................................................................................... 3-6

Preparing for operation.......................................................................................................................... 3-6

mini API

®

Instrument User's Manual V-1

Table of contents

4 Set-Up 4-1

Starting mini API®..................................................................................................................................... 4-1

Adjusting the contrast and brightness of the screen.................................................................................. 4-2

Printer operation........................................................................................................................................ 4-3

Functions............................................................................................................................................... 4-4

Checking the operation of the printer (self-test) ........................................................................................ 4-5

Stopping mini API®................................................................................................................................... 4-6

5 Using mini API® 5-1

Procedure for use...................................................................................................................................... 5-1

6 Maintenance 6-1

Testing mini API®..................................................................................................................................... 6-2

Maintenance.............................................................................................................................................. 6-3

Cleaning mini API®............................................................................................................................... 6-3

Changing the ribbon.................................................................................................................................. 6-9

Changing the roll of paper....................................................................................................................... 6-11

Changing the fuse................................................................................................................................... 6-13

7 Troubleshooting 7-1

8 DENSIMAT densitometer 8-1

9 Electronic pipette 9-1

10 Appendices 10-1

Appendix A: Installing MS DOS 6.22 or later versions ............................................................................ 10-1

Appendix B: Installing the mini API® CONFIGURATION floppy disk...................................................... 10-2

Appendix C: Protecting data on floppy disks through write inhibit........................................................... 10-3

11 Glossary 11-1

12 Index 12-1

Notes Notes-1

V-2 mini API® Instrument User's Manual

List of figures

2 Functional description of mini API

Fig. 2-1: Configuration components ........................................................................................................ 2-1

Fig. 2-1 : Using mini API®....................................................................................................................... 2-3

Fig. 2-2: Description of the spectral zone................................................................................................ 2-6

Fig. 2-3: Reading principle of the test strip reader .................................................................................. 2-6

3. Preliminary instructions

Fig. 3-1: Setting up the strip carriage...................................................................................................... 3-5

Fig. 3-2: Connections.............................................................................................................................. 3-6

4. Set-Up

®

Fig. 4-1: Back panel of mini API

Fig. 4-2: Adjusting the contrast and brightness of the screen ................................................................. 4-2

Fig. 4-3: Printer control panel.................................................................................................................. 4-3

Fig. 4-4: Print-out during the self-test...................................................................................................... 4-5

5. Using mini API®

Fig. 5-1: Position of the strip carriage and the protection rail .................................................................. 5-3

6. Maintenance

........................................................................................................... 4-1

Fig. 6-1: Strip carriage assembly. ........................................................................................................... 6-4

Fig. 6-2: Strip carriage ............................................................................................................................ 6-4

Fig. 6-3: Preparing the photodiode cleaning tool..................................................................................... 6-7

Fig. 6-4: Cleaning the photodiodes ......................................................................................................... 6-7

Fig. 6-5: Printer cover ............................................................................................................................. 6-9

Fig. 6-6: Paper cutter .............................................................................................................................. 6-9

Fig. 6-7: Changing the ribbon ............................................................................................................... 6-10

Fig. 6-8: Loading paper......................................................................................................................... 6-12

Fig. 6-9: Back panel of mini API®......................................................................................................... 6-13

mini API

®

Instrument User's Manual VI-1

1 How to use this manual

Introduction

The mini API® Instrument Manual deals solely with the instrument and
consumables. It includes the information you need for the installation, set-up
and maintenance of mini API

The software and the procedures for use are described in the mini API
Procedures Manual.

®

.

®

CAUTION! The user is advised to read and understand all instructions in this manual

to be able to derive the best performance from mini API

®

.

mini API® Instrument User's Manual 1-1

How to use this manual

Finding topics and procedures

Finding topics and procedures

The information in the manual is organized in 12 chapters. The first 7 contain
the topics and procedures.

- Chapter 8 describes the DENSIMAT densitometer.

- Chapter 9 describes the electronic Pipette.

- Chapter 10 includes the Appendices.

- Chapter 11 is the glossary.

- Chapter 12 is the Index.

Table of contents

List of figures

Graphic symbols

Page headers and
page footers

Glossary

Index

The main table of contents of the manual is located on pages V-1 to V-2.
It lists each chapter and the procedures and/or topics contained in the manual.

Page VI-1 contains the list of figures found in this manual.

The standard symbols used for our instruments and their meanings can be
found in this list (Page 1-4 to 1-6).

Apart from the first page of every chapter, each page of the manual includes a
page header and a footer.
Each page header includes the chapter title and the title of a procedure or its
corresponding description.
These titles are located on the outside of the page so that you can thumb
through the pages to quickly locate a chapter or a procedure.
The footers contain the title of the manual, the name of the product and the
page number.

The glossary is located in chapter 11 at the back of the manual. It gives the
definition of the main technical terms used in the manual.

The index is located in chapter 12 at the back of the manual. It is used to locate
a particular description or procedure.

1-2 mini API® Instrument User's Manual

How to use this manual

Typographic conventions

Typographic conventions

Following are the terms and visual cues used in this manual to aid in your

·

<Return>

<Ctrl>

E.g.:

<Esc>

<NumLock>

<>, <¯>, <¬> and
<®>

ABC 123 This typography is used for messages that appear on the screen.

understanding of the procedures.

The bullet point is used to denote an action to be performed.

Can also be <

This key is always associated with another key.

Both keys should be pressed simultaneously.

Press <Ctrl> U.

This key is sometimes used to quit the menu.

This key must be activated (light on) before you can use the numeric
keyboard.

These keys enable you to move the cursor in different directions on the
screen.

The <> key is also called <Cursor up> in the software.

> or <Enter> depending on the type of keyboard.

8

1

2

3

ABC 123

mini API® Instrument User's Manual 1-3

E.g.: C : \ >

This typography is used to represent a text to be typed through the computer
keyboard.

E.g.:

· Type: APICONF

4

5

How to use this manual

Graphic symbols

Graphic symbols

V.A 09/2003

The standard symbols used for our systems and their meanings can be found
below:

Direct current

Alternating current

Both direct and alternating current

Three-phase alternating current

Earth (ground) TERMINAL

PROTECTIVE CONDUCTOR TERMINAL

Frame or chassis TERMINAL

Equipotentiality

ON (power supply)

OFF (power supply)

1-4 mini API® Instrument User's Manual

How to use this manual

Graphic symbols

ON" (only for a component of the system equipment)

"OFF" (only for a component of the system equipment)

Equipment protected throughout by DOUBLE INSULATION or

i

REINFORCED INSULATION (equivalent to Class II of IEC 536)

Caution !: risk of electric shock
(background color: yellow, symbol and outline: black)

Caution !: see accompanying documents
(background color: yellow, symbol and outline: black)

Caution !: high temperature

Caution !: potential pinch point

Caution !: potential biohazard

Consult instructions for use

1

2

3

4

LOT

REF

EC REP

mini API® Instrument User's Manual 1-5

Batch code

Catalogue number

Temperature limitation

Authorised representative

5

How to use this manual

Graphic symbols

Keep dry

IVD

SN

Manufactured by

Date of manufacture

In vitro diagnostic medical device

Serial number

Keep away from magnetic field

1-6 mini API® Instrument User's Manual

®

2 Functional description of mini API®

Introduction

This manual deals with the mini API® instruments and consumables.

The software is described in the mini API

Description / aim

mini API® is designed for the automatic identification and susceptibility testing of
ID 32, rapid ID 32, ATB® and rapid ATB® strips.

It also enables computer assisted interpretation of API

®

Procedures Manual.

®

strips read visually.

mini API

¬ -mini API
 -Keyboard
® -Electronic pipette
¯ -DENSIMAT densitometer

Fig. 2-1 : Configuration components

®

Instrument User's Manual 2-1

Functional description of mini API®

Configuration components

Configuration components

mini API® is an automated instrument for identification and susceptibility testing.

It consists of:

- the hardware,

- the software,

- the consumables.

Hardware

Software

The package includes:

®

- mini API

, a self-contained analytical module enabling:

. reading of test strips,

. management of results and data,

. printing of results obtained,

- a DENSIMAT densitometer to standardize the turbidimetry of the bacterial

suspension (please refer to the manual supplied with the densitomer).

- an electronic Pipette to dispense the required amount of bacterial

suspension into each cupule of the identification and susceptibility test strips
(55 µl or 135 µl) (please refer to the manual supplied with the pipette).

The mini API software enables:

- interpretation of data,

- interpretation of strip results (identification or susceptibility tests),

- expert analysis of susceptibility tests,

- storage of results on the hard disk,

- printing of results,

- extraction of data,

- connection with a central computer.

Consumables

The mini API® consumables include:

- strips with associated media and reagents

(see package inserts),

- ribbons and paper for the printer,

- pipette tips.

2-2 mini API® Instrument User's Manual

Functional description of mini API®

Configuration components

Isolation

Isolation medium.

Orientation tests

Choice of

strips

Automated technique

Standardized

inoculation using the

electronic pipette

Standardization of the

inoculum using the

DENSIMAT

Manual technique

1

2

ATB or rapid ATB strips ID 32 or rapid ID 32 strips

Automatic reading
and interpretation.

Visual reading.

Entry of biochemical profiles

via keyboard.

Automatic interpretation.

3

4

5

Fig. 2-2 : Using mini API

®

mini API® Instrument User's Manual 2-3